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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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As industry associations call on Food and Drug Administration (FDA) to increase regulatory oversight on the servicing of medical devices, a lack of evidence to “justify imposing additional/different burdensome regulatory requirements at this time” caused agency staff to take a different approach, a new report concludes.

Manufacturers that contract third-party servicers have raised several issues and concerns over the past few years regarding inadequate handling of devices, urging for regulatory controls in the servicing space.

In a new first-of-its-kind report mandated under section 710 of the FDA Reauthorization Act of 2017 (FDARA), the agency’s Center for Devices and Radiological Health (CDRH) on Tuesday outlined four areas in which it will pursue actions aimed at addressing the device firms’ concerns with a different approach.

The new actions identified in the report include working in collaboration with servicing firms to establish a voluntary medical device servicing framework to promote the adoption of quality management principles. “We view this strategy, rather than a formal regulatory approach mandating adoption of FDA’s [Quality System] regulation by all entities performing medical device servicing, as the appropriate approach at this time for advancing the quality of medical device quality servicing,” CDRH said.

Medical device servicing has been a top priority at several industry associations such as the Medical Imaging Technology Association (MITA) and the Association for the Advancement of Medical Instrumentation (AAMI)—both of which are developing or revising standards on the matter.

“Right now, only manufacturers are regulated by FDA when it comes to medical device servicing,” MITA Director of Policy and Strategy Peter Weems told Focus. However, independent servicing companies have an entire other industry without any FDA regulations or oversight, he noted.

Third-party servicers—which includes those that conduct “refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device,” per FDARA’s definition—are not currently required to be registered with FDA, report adverse events associated with a device they serviced or have a quality management system program in place, though there are some that do.

“Clearly, that’s an issue that we’re concerned about because if you have somebody who is untrained or using unqualified parts, or tampering with the device, that has patient safety implications and could also affect the integrity of the performance of the device,” Weems said.

Still, CDRH was unable to determine whether this issue is of “widespread public health concern,” despite receiving 186 comments on this in a Federal Register docket from March through early June 2016, followed by an October 2016 public workshop where industry associations voiced concerns.

The industry associations also provided real-life examples and case studies of the problems that emerge over the lack of regulatory oversight in the servicing space. The use of “improper parts, devices not being put back together correctly, things not cleaned appropriately” are just some of the issues MITA member companies have dealt with in the past when working with third-party servicers, Weems said.

With the rapidly changing device regulatory landscape, priorities shifted at FDA and this caused any progress made on addressing the issues with device servicing to be stalled, according to Weems.

MITA—which has been working to establish a related standard, validated late 2017 on basic risk-based quality management system requirements, with input from device firms, independent servicers, clinical engineers, hospitals, FDA, among other stakeholders—was expecting to be disappointed with the new report and the lack of regulatory controls being “a missed opportunity on FDA’s part,” Weems added.

“FDA believes there are approximately between 16,520 and 20,830 servicers active in the US,” spokesperson Stephanie Caccomo told Focus.

The new approach set forth in CDRH’s report banks on at least some medical device servicers having already adopted quality management principles, such as with international standard ISO 13485.

But Jim Spearman, president of the Consensys division at device service distributor Merry X-Ray, told Focus the total number of medical device servicing firms that have been in compliance with the existing quality standards for anything more than two years is a “significant minority,” estimating this to be at about a mere 10%.

Getting quality certifications may be feasible but maintaining them over a period of time is “extremely difficult” because of the need for a sustainable infrastructure that can keep pace with changes in regulatory policies and procedures—which may be out of reach for smaller firms, Spearman argued.

Spearman disagreed with CDRH’s decision for quality compliance to continue being a voluntary option for independent servicers because even when it is mandatory, there are remaining challenges with tracking real-world evidence on devices and this was made clear with the report’s findings.

Shortcomings, such as “persistent underreporting of patient safety events and device malfunction,” with the current requirements on medical device reporting (MDR) are among the reasons cited for concluding that the evidence analyzed was insufficient to extend FDA's regulatory reach across third-party servicers.

These shortcomings, however, raised a red flag with regards to FDA’s monitoring on compliance to MDR requirements, Spearman noted. Legislative action may be needed to address the many real-life examples that go unreported by manufacturers, which rely on customers to provide the information, he added.

Further, while firms are required to report to FDA when a device is likely to have contributed to a death or serious injury, servicing history is excluded in the types of information that should be in an MDR.

“Without this information, it is difficult to establish a definitive link between the servicing of a device and the reported event,” CDRH’s report states. As FDA continues to promote quality principles adoption across the total product lifecycle, this is a blind spot that remains unaddressed.

Other ongoing CDRH activities intended to improve quality of device servicing include issuing draft guidance to provided clarifications on the differences between servicing and remanufacturing. In contrast with independent servicers, remanufacturers are subject to FDA requirements.

CDRH also intends to strengthen cybersecurity practices among independent third-party servicing firms through the development and application of standards and best practices.

Mixed Reactions

Focus received comments from AdvaMed and MITA in response to CDRH’s report, expressing disappointment with the decision against extending regulatory controls on third-party servicers.

“Today’s report from FDA was disappointing, given the agency’s decision not to exercise its authority over unregulated third-party servicers,” said AdvaMed Chief Advocacy Officer JC Scott. “The limited actions proposed in FDA’s report, while welcome, do not go far enough to address the scope of the problem effectively. Congress can and should still take action to provide at least some minimal level of control over these entities while the FDA continues to evaluate the risks to patients.”

Focus also received a comment from AAMI in support of the report being “a significant positive step toward progress in the servicing of medical devices,” said President and CEO Robert Jensen.

“There is a strong commitment on the part of FDA to promote quality management principles and strengthen cybersecurity practices,” Jensen added. “AAMI has plans to develop a medical device servicing guide to provide the stakeholder community an opportunity to pilot and give feedback on actionable, pragmatic quality management practices and potential evidence development.”